510(k) K240058
- Device
- AEYE-DS
- Applicant
- Aeye Health, Inc.
- 510(k) number
- K240058
- Product code
- PIB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-04-23
- Date received
- 2024-01-08
- Regulation
- 886.1100
- Classification name
- Diabetic Retinopathy Detection Device
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Zack Dvey-Aharon
- Address
- 200 Park Ave. (17th Floor) New York NY US 10166 10166
FDA Registration Numbers#
- 3014579028
- 3025301728
- 3013924858
Source Documents#
Other 510(k) Records For Product Code PIB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223357 | EyeArt v2.2.0 | Eyenuk, Inc. | 2023-06-16 |
| K221183 | AEYE-DS | Aeye Health, Inc. | 2022-11-10 |
| K213037 | IDx-DR v2.3 | Digital Diagnostics, Inc. | 2022-06-17 |
| K203629 | IDx-DR | Digital Diagnostics, Inc. | 2021-06-10 |
| K200667 | EyeArt | Eyenuk, Inc. | 2020-08-03 |
| DEN180001 | IDx-DR | Idx, LLC | 2018-04-11 |